Cassava Intervention Project

NCT03157336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2022-06-06

No results posted yet for this study

Summary

Investigators will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists.

Conditions

  • Neurotoxicity Syndrome, Cassava
  • Neurotoxicity Syndrome, Cyanate
  • Neurotoxicity Syndrome, Cyanide
  • Neurotoxicity Syndrome, Thiocyanate

Interventions

OTHER

Non Inferiority WTM Interventional Trial

The intervention will implement the WTM cassava processing technique in participating households. Twenty women (in leading roles) will be our principal candidates to serve as peer trainers. Together with a 20 community health worker specialists, these women will be trained in the WTM technique by the Kinshasa team of community health workers who are experts in the WTM method. Those who master the technique will then be certified as trainers to train and support other small groups of other mothers throughout a two-year period in the implementation of the WTM for the safer processing of food for their families. Both the community health worker specialists and trained women (prospective trainers) would have to be able to bring the cassava cyanogenic content to the lowest achievable level, which must be \< 10 ppm as per the recommendations of the World Health Organization.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Oregon Health and Science University

    collaborator OTHER
  • Michigan State University

    collaborator OTHER
  • University of Kinshasa

    collaborator OTHER
  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH
  • Ministry of Public Health, Democratic Republic of the Congo

    lead OTHER_GOV

Principal Investigators

  • Mumba Ngoyi · Ministry of Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-30
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • Democratic Republic of the Congo

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03157336 on ClinicalTrials.gov